Maintenance Manager, Calibrations
Maintenance Manager, Calibrations
United States - California - La Verne
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Specific Job Responsibilities:
- Accountable for the execution of the instrumentation/calibrations and metrology services and activities in the site.
- Accountable of the Instrumentation/Calibrations group to assure that required process, laboratories, utilities and facilities equipment calibrations are performed in compliance with NIST, cGMP regulations, company policies and procedures and meet Federal and local governmental regulation (e.g. FDA, EQB, OSHA, etc.).
- Leads the execution of Metrology activities in accordance to stipulated production schedule and compliance requirements.
- Responsible for the efficient deployment of resources to ensure department complies with calibration schedules in support of the site manufacturing schedule. Provides solution-solving techniques and/or troubleshoots routine and unusual problems.
- Ensures that all operations in all areas of responsibility are performed in compliance with cGMP Regulations and Company Policies/Procedures, also makes sure that personnel is trained in cGMP's and SOP's.
- Encourage team to create, identify and implement new and innovative ideas/technologies for the successful development of business opportunities within and outside of the Instrumentation/calibrations area.
- Understands and applies root cause analysis principles and find solutions for equipment issues.
- Establishes key performance metrics which monitor and assist the team to understand maintenance services performance and can be used to improve the productivity and quality of production processes.
- Manages the staff training and development strategy and ensures that staff is technically trained in complex pharmaceutical plant utilities maintenance activities.
- Maintains site compliance documentation and investigates and responds to compliance problems and complaints received from customers, agencies, or employees.
- Prepares and delivers performance appraisals to all employees in their organization.
- Executes employees' performance improvement plans, development and disciplinary actions as required.
- May participate in audits to include internal, vendors or contract manufacturers.
- Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
- Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data .
- Ability to troubleshoot problems for highly technical equipment.
- Proficient knowledge of asset life cycle management, change control systems, FDA regulatory requirements, including 21 CFR Part 11 and documentation procedures pertaining to a pharmaceutical manufacturing plant such as cGMP's, SOP's, among others.
- Proven ability to develop short and long term plans to meet business direction/initiatives and comply with all legal obligations
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Able to read, interpret, and understand electrical/mechanical drawings.
Specific Education & Experience Requirements:
- 7+ years of relevant experience (see below) and BA in related fields.
- Fifteen (15) years of experience in instrumentation technology for processing, laboratories, utilities and facilities equipment in a pharmaceutical manufacturing environment and a High School diploma.
- Five (5) years' experience in a supervisory role in a pharmaceutical environment.
- Previous experience in biotech or pharmaceuticals industry desirable.
- Previous experience working in highly regulated manufacturing environments desirable.
- Proficient in Microsoft Office applications and Engineering Application such as MAXIMO.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---La-Verne/Metrology-Manager_R0021707-1
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